MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL; INTRAOCULAR LENS

Model Number	DAT015
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient states that, she felt issue with the lens (unspecified) as it was not performing as expected.The patient depth of perception is off, she is unable to drive comfortably.The patient has a sweet spot at about three feet that she can see clearly.The patient has a dark shadow peripherally (half moon), that she felt it is getting larger.The patient has seen a retinal specialist and was told everything was fine but did have mild macular degeneration.The patient physician stated, she needs to have yttrium aluminum garnet (yag) but once that is done would not be able to have any additional procedures.The patient¿s doctor also performed "bag" procedure with a membrane that was placed on her cornea to help healing, after the surgery in her left eye she had to have "tap" due to increase pressure.The patient used additional drops that samples were provided to help with intraocular pressure (iop).There are two medical device reports associated with this patient, this report is for left eye.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.Two other complaints reported for the lot.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was retuned in a clear water-like liquid inside specimen cup.The optic is cut into two portions, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.Power and resolution testing could not be conducted due to the extensive optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided that the company lens, 22.0 diopter extended 1.5 diopters of focus) lens was replaced with a non-company monofocal 21.0 diopter lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, the explant is performed for left eye.

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14204557
• Report Number: 1119421-2022-00846
• Device Sequence Number: 1841410
• Product Code: POE
• UDI-Device Identifier: 00380652424677
• UDI-Public: 00380652424677
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2026
• Device Model Number: DAT015
• Device Lot Number: 15225937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female